Regulation: A Burden in Biopharmaceutical Industry? The Case of EU-Risk Management Plans

The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market.

Regulation: A burden in biopharmaceutical industry? The case of EU-risk management plans

The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market. © 2010 IEEE.

Issues of HIV/AIDS/ health among the fisher communities of Lake Albert and Kyoga

The fisheries resources of Lakes Albert and Kyoga present a high potential for economic growth, food, employment and foreign earnings. However, livelihoods appear to be compromised with the emergence and rapid spread of HIV/AIDS in the fisher communities of L. Albert and Kyoga. HIV/AIDS is considered a silent epidemic that is unique, posing a great challenge to the fisheries managers, health service providers, development planners and the resource users themselves. Fishers have high HIV prevalence, as well as AIDS-related illnesses and mortality rates. The high HIV prevalence rates among the fishing communities in Uganda is between 10-40% compared to the national rates which lie between 6% and 7%. This indicates that the national programmes have not adequately addressed the plight of the fishing communities of Lakes Albert, and Kyoga and the consequences have been devastating. Men and women living in fishing villages across the world have been found to be between five and ten times more vulnerable to the disease than other communities (Tarzan et al 2005, FAO, 2007). The present prevalence rates among the fishing communities stands at 10 to 40 % (LVFO, 2008). Meanwhile the same fishing communities are the essential labour for the Lakes’ fishery industry which is thriving nationally and internationally. That resource potentially can alleviate poverty and the HIV/AIDS threat. Fishing communities are the hidden victims of the disease, mixing patterns with the general population could act as a reservoir of infection that could spill over into the general population to drive the epidemic. On L. Albert, a quarter of the fisher folk were HIV-positive by 1992 compared to 4% in a nearby Agricultural village. Since then, there have been no targeted studies to address or monitor the prevalence rates eight years later, yet the multiplicity factor is high. HIV/AIDS can be linked to unsustainable fisheries, as the labour force available would not go to deep waters to fish, instead would fish in the shallow waters as a coping mechanism. A further effect is the loss to National and local economies and reduced nutritional security for the wider population. HIV/AIDS remains a significant challenge that has created a mosaic of complexity in the fishery sector. This needs to be addressed. It is, therefore, paramount that a comprehensive study was under taken to address this pandemic and the phenomenon of HIV/AIDS based on the study objectives. 1. To determine the trend in HIV/AIDS infection among fishing communities and the factors affecting it 2. To assess the impacts of HIV/AIDS on fish production and the implications for fisheries management.

Comparative analysis of carbonization drivers in China's megacities

This study investigates the key drivers affecting emission increases in terms of population growth, economic growth, industrial transformation, and energy use in six Chinese megacities: Beijing, Shanghai, Tianjin, Chongqing, Guangzhou, and Hong Kong. The six cities represent the most-developed regions in China and they have similar per capita carbon dioxide (CO 2) emissions as many developed countries. There is an urgent need to quantify the magnitude of each factor in driving the emissions changes in those cities so that a potential bottom-up climate mitigation policy design at the city and sectoral levels can be initiated. We adopt index decomposition analysis and present the results in both additive and multiplicative approaches to reveal the absolute and relative levels of each factor in driving emission changes during 1985-2007. Among all cities, economic effect and energy intensity effect have always been the two dominant factors contributing to the changes in carbon emissions. This study reveals that there are large variations in the ways driving forces contribute to emission levels in different cities and industrial sectors. © 2012 by Yale University.

Roadmapping an emerging energy technology: An ex-ante examination of dimethyl ether development in China

Technology roadmapping has been used to strategise the development of energy technologies. However, there have been limited roadmapping applications that analyse the emergence of a new energy technology that then forms a new industry and propels broad-based low-carbon economic growth. This paper, therefore, attempts to develop a roadmapping framework by integrating the lifecycle analysis tool, in order to strategise the emergence of dimethyl ether, an alternative energy based on advanced engineering technologies such as carbon capture and storage. This paper compares two scenarios of dimethyl ether vs. diesel and finds that the superiority of dimethyl ether will not arise until 2030, when the complementary engineering technologies become available. This proposed framework can also be generalised to other clean energy industries, and we anticipate our paper will spark inspiration for roadmapping and strategising the 'right' technologies for the growth of Chinese energy industries. Copyright © 2012 Inderscience Enterprises Ltd.

Chinese studies on the edible blue-green alga, Nostoc flagelliforme: a review

Nostoc flagelliforme, which is distributed in arid or semiarid steppes of the west and west-northern parts of China, has been used by the Chinese as a food delicacy and for its herbal values for hundreds of years. However, the resource is being over-exploited and is diminishing, while the market demands are increasing with the economic growth. This review deals mainly with the Chinese studies on the ecology, physiology, reproduction, morphology and culture of this species in an attempt to promote research and development of its cultivation technology.

Essential elements of integrated coastal zone management

The coastal zone comprises a narrow strip of coastal lowlands and a vast area of coastal waters. While the coastal zone represents approximately 10% of the earth's surface, its coastal lowlands are inhabited by more than 50% of the world population. The coastal zone has become the major site for extensive and diverse economic activities. Many of the coastal developing countries depend heavily on the scarce coastal resources for their economic growth.

Analysis of spatio-temporal dynamic pattern and driving forces of urban land in China in 1990s using TM images and GIS

China has witnessed fast urban growth in the recent decade. This study analyzes spatio-temporal characteristics of urban expansion in China using satellite images and regionalization methods. Landsat TM images at three time periods, 1990/1991, 1995/1996, and 1999/2000, are interpreted to get 1:100000 vector land use datasets. The study calculates the urban land percentage and urban land expansion index of every 1 km(2) cell throughout China. The study divides China into 27 urban regions to conceive dynamic patterns of urban land changes. Urban development was achieving momentum in the western region, expanding more noticeably than in the previous five years, and seeing an increased growth percentage. Land use dynamic changes reflect the strong impacts of economic growth environments and macro-urban development policies. The paper helps to distinguish the influences of newly market-oriented forces from traditional administrative controls on China's urban expansion. (c) 2005 Elsevier Ltd. All rights reserved.

Environmental Kuznets Curve for SO_2 Emissions in China

This study examines the link between the economic growth and the environmental quality. Based on a panel data set, a N-shaped Environmental Kuzents Curve has been found for the sample period: a cubic relationship between per capita GDP and emissions of sulphur dioxide (SO2). We also find that energy consumption is an important determinant of environmental degradation. The empirical results suggest that we should promote environmental protection as soon as possible.

动漫行业创业者胜任特征研究

Venture has become an important force for the sustainable economic growth of China, However, research on entrepreneurs is far failed to meet the actual needs, Animation and Comic Industry is an important component of the state-led Cultural and Creative Industries. Entrepreneurship is the rapid growth of population, but the empirical research on the Animation and Comic Industry entrepreneurs’ Competent Characteristic Model is rarely heard. As a manager of a national incubator which major in Cultural and Creative Industry, study these entrepreneurs competent characteristics is my responsibility. As an exploration, the study uses Competent Characteristic Model of classical design methods and behavior events interview method, and selects entrepreneurs which of animation and comic industry business start-up period as the objects. Through coding analysis of 31 entrepreneurs’ interview information, completed the amendment to the dictionary coding, and ultimately construct the animation and comic industry entrepreneurs need to have the threshold competence model and differentiating competence model. Differentiating competence model includes six competencies: tolerance and optimism, cooperation, creative innovation, pool talents, vision, decision-making and tempo control. Threshold competence model includes twenty features, divided into three dimensions: personal characteristics, knowledge quality, capacity of the quality. Knowledge and capacity of the quality are closely related to the core work of entrepreneurs, Personal characteristics concern the deep-seated motivation of the entrepreneurs. The study also analyses and discusses the characteristics of the entrepreneurs on the demographic variables.

Competitiveness in a globalised world: Michael Porter on the microeconomic foundations of the competitiveness of nations, regions, and firms.

In this paper, we provide the text of an interview with Professor Michael Porter discussing his research and ideas relating to the microeconomic foundations of global competitiveness. The discussion provides a microeconomic perspective on some of the key issues relating to recent research on competitiveness, productivity, clusters, US economic leadership, economic growth and development.

Health, security and foreign policy

McInnes, C., Lee, K. (2006). Health, security and foreign policy. Review of International Studies, 32 (1), 5-23. RAE2008

Vantagens do ciclo combinado a gás natural face a outras tecnologias de produção de energia. Estudo de caso

Seria impensável concebermos os nossos dias sem a utilização de energia eléctrica. Esta forma de energia é responsável pelo desenvolvimento económico e a sua disponibilidade é indicadora da qualidade de vida dos povos. A procura de formas de obtenção desta energia que minimizem os impactes para o ambiente tem levado à adopção de energias renováveis mas também ao desenvolvimento de novas tecnologias que permitam aumentar a eficiência de conversão de energia entre as suas várias formas. Neste sentido procedeu-se à análise de um estudo de caso da central termoeléctrica a gás natural com tecnologia de ciclo combinado da Tapada do Outeiro, Portugal. Living without electricity is nowadays unconceived. The economic growth and quality of life is strongly dependent on this source of energy. The search for new forms of producing electricity in order to minimise environmental impacts has lead to the adoption of renewable energies and to the improvement of new technologies which allow at the same time to reach high efficiency in the process of energy conversion from the chemical form to the electrical one. This article is about a case study of a natural gas turbine power plant with combined cycle, at “Tapada do Outeiro”, Portugal.

The financial storms in Vietnam's transition economy: a reasoning on the 1991-2008 period

This study focuses on those substantial changes that characterize the shift of Vietnam’s macroeconomic structures and evolution of micro-structural interaction over an important period of 1991-2008. The results show that these events are completely distinct in terms of (i) Economic nature; (ii) Scale and depth of changes; (iii) Start and end results; and, (iv) Requirement for macroeconomic decisions. The study rejected a suspicion of similarity between the contagion of the Asian financial crisis in 1997-98 and economic chaos in the first half of 2008 (starting from late 2007). The depth, economic settings of, and interconnection between macro choices and micro decisions have all grown up significantly, partly due to a much deeper level of integration of Vietnam into the world’s economy. On the one hand, this phenomenon gives rise to efficiency of macro level policies because the consideration of micro-structural factors within the framework has definitely become increasingly critical. On the other and, this is a unique opportunity for the macroeconomic mechanism of Vietnam to improve vastly, given the context in which the national economy entered an everchanging period under pressures of globalization and re-integration. The authors hope to also open up paths for further empirical verifications and to stress on the fact that macro policies will have, from now on, to be decided in line with changing micro-settings, which specify a market economy and decide the degree of success of any macroeconomic choices.

Resource Curse or Destructive Creation: A Tale of Crony Capitalism in Transition

This paper explores the “resource curse” problem as a counter-example of creative performance and innovation by examining reliance on capital and physical resources, showing the gap between expectations and ex-post actual performance became clearer under conditions of economic turmoil. The analysis employs logistic regressions with dichotomous response and predictor variables, showing significant results.Several findings that have use for economic and business practice follow. First, in a transition period, a typical characteristic of successful firms was their reliance on either capital resources or physical asset endowments, whereas the innovation factor was not significant.Second, poor-performing enterprises exhibited evidence of over reliance on both capital and physical assets. Third, firms that relied on both types of resources tended to downplay creative performance. Fourth, reliance on capital/physical resources and adoption of “creative discipline/innovations” tend to be mutually exclusive. In fact, some evidence suggests that firms face more acute problem caused by the law of diminishing returns in troubled times. The Vietnamese corporate sector’s addiction to resources may contribute to economic deterioration, through a downward spiral of lower efficiency leading to consumption of more resources. The “innovation factor” has not been tapped as a source of economic growth. The absence of innovations and creativity has made the notion of “resource curse” become identical to “destructive creation” implemented by ex-ante resource-rich firms, and worsened the problem of resource misallocation in transition turmoil.